Clinical Research Associate II

Job Title

Responsible for providing Clinical Research support for all clinical trials.

Essential Duties And Responsibilities:

• Participate and assist in design and preparation of protocols and case report forms.
• Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.
• Participate in the evaluation of potential clinical sites according to established criteria of acceptability.
• Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions.
• Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.
• Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions.
• Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites.
• Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission.
• Assist with the maintenance of clinical archive and electronic files.
• Other tasks as assigned.

Requirements:

• BA, BS, RN, BSN or equivalent
• Basic knowledge and adherence to GCPs
• 1-2 years of clinical research experience or equivalent experience or training
• Strong attention to detail
• Ability to multi-task
• Unquestionable integrity and highest ethical standards
• Excellent written and verbal communication skills
• Self-motivated, assertive, and driven

Benefits:

• Dental, Medical, Vision and 401K